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Hilton Toronto

May 21, 2015 7:30 AM - May 21, 2015 5:00 PM

145 Richmond Street West, Toronto, ON M5H 2L2, Canada

DIA Canadian Pharmacovigilance & Risk Management Meeting

Overview

Tutorial: May 20, 2015
Meeting: May 21, 2015

This 1-day meeting will provide new insights into the current issues and associated challenges impacting drug safety in Canada. Expert pharmaceutical, biotechnology, and regulatory thought leaders will discuss Regulatory Guidance Document Updates, the impact of Bill C-17 on adverse drug reaction reporting, Pharmacovigilance (PV) Agreements, eReporting, special product areas; and much more.

Session topics to include:

  • ADR Reporting Guidance
  • Annual Summary Reporting Guidance
  • Risk Management Guidance
  • Benefit-Risk Assessment Guidance
  • Q&A with Inspectorate
  • Industry Perspective on Medical Devices and Combination Products
  • Generics
  • OTCs and Natural Health Products

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Continuing-Education

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Who should attend?

Professionals who are involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Research
  • Data Analysis
  • Pharmacoepidemiology
  • Medical Information
  • Health Outcomes

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Describe the current Canadian regulatory framework for pharmacovigilance
  • Discuss operational challenges of implementing benefit-risk analyses and risk management plans

Short Course or Primer

To keep you at the forefront.

May 20, 2015

Tutorial 1:

PBRERs

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Program Committee

  • Marcia Bailey, BSN, MHS, RN
    Marcia Bailey, BSN, MHS, RN Safety Evaluation and Risk Management Scientific Director
    GSK, Canada
  • Rita Cassola, RPh
    Rita Cassola, RPh Executive Director PV
    Certus PV Services Inc, Canada
  • Rebecca Noel, DrPH, MPH
    Rebecca Noel, DrPH, MPH Executive Director, Benefit-Risk Assessment
    Eli Lilly, United States
  • Marc Poitras, PhD, MBA
    Marc Poitras, PhD, MBA Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
    Health Canada, Canada

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